Vaccine Safety Assessment

During clinical trials, safety cannot be assessed directly but only inferred from the relative absence of AEFIs (Adverse Events Following Immunisation). Comparison and meta-analysis of safety results for a same type of vaccine formulation and/or different vaccines using same technologies or adjuvants require standardised case definitions and guidelines for AEFI

INYVAX will increase the awareness of Brighton safety standards among the project participants and stakeholders in international vaccine development and improve the applicability and “user-friendliness” of Brighton case definitions, data collection guidelines, and online tools.

A template of safety section in clinical trial protocols including data collection, analysis and reporting is being developed. Further, a list of AEFI specifically relevant for PRD vaccines, for which development of harmonised case definitions is needed, will be developed.

News

09.11.2012
In addition to the initial groups, TRANSVAC transnational access platform has integrated five additional groups, who provide their services to users on a free and paid basis. Read the TRANSVAC Press release about the new services.
22.08.2012
The European Vaccine Initiative is publishing a Press Release for the PRIMALVAC project, which aims at developing a vaccine to prevent Pregnancy Associated Malaria.

13.08.2012
There is currently a vacancy EVI for a Business Assistant, deadline for applications 7 September 2012